effects of vardenafil on clinical symptoms and peripheral blood flow in patients with raynaud's syndrome

Conditions: Raynaud Syndrome

Summary: the purpose of this study is to determine whether vardenafil is effective in improving clinical symptoms and peripheral blood flow in patients with primary and secondary raynaud phenomenon.


Eligibility criteria:
inclusion criteria: * raynaud-syndrome (primary or secondary) \> 1 year duration * age ≥ 18 years; ≤ 80 years * informed consent * a negative pregnancy test in women of child-bearing age exclusion criteria: * any unstable organic, psychiatric or addictive disease, which - in the opinion of the investigators - might result in an unsuccessful / unreliable participation or premature termination of the trial * known contraindications against pde 5-inhibitors (such as intolerance, therapy with nitrates or inhibitors of cyp3a4, etc.) * extensive necrosis of the finger tips * pigmentary retinopathy * verification as a hbsag or hepatitis c carrier * unstable angina * heart failure (nyha iii or iv) * valve defects of higher degree (particularly aortic stenosis and hypertrophic obstructive cardiomyopathy) * myocardial infarction, stroke or life-threatening cardiac arrhythmias within the last 6 months * uncontrolled atrial fibrillation / -flutter with a heart rate \> 100 bpm * prolonged qtc-interval (\> 450 msec) * congenital long-qt-syndrome * hypokalemia * severe acute or chronic liver disease, which might lead to priapism (sickle cell anemia, leucemia) * hemophilia * active peptic ulcers * arterial hypotension (systolic blood pressure at rest \<90 mmhg) or * arterial hypertension(systolic blood pressure at rest \>170 mmhg or diastolic blood pressure at rest \>110 mmhg) * malignancy within the last 5 years (except squamous or basal cell skin cancer) * patients with injuries of the spinal cord or central nervous system * patients with severe chronic kidney disease (creatinin clearance \< 30 ml) * patients with mild to severe liver disease (child-pugh a-c) * age below 18 or above 80 * prohibited concomitant medication during the study: * nitrates or other no-donators (including amylnitrit) * anticoagulative drugs except inhibitors of thrombocyte function * androgens (such as testosterone) or anti-androgens * strong inhibitors of cytochrome p4503a4: * very potent hiv-protease-inhibitors (ritonavir, indinavir) * anti-mycotic like itraconazole and ketoconazole (topical applications are allowed) * erythromycin * grapefruit-juice or products containing grapefruit-juice * other study medications (including placebo) up to 30 days before study inclusion * therapy of erectile dysfunction(including sildenafil, sublingual apomorphin, muse®, intracavernous injections or vacuum pumps) or other therapies of erectile dysfunction within 4 weeks and during the trial period * nebivolol * alpha-blockers * calcium antagonists * medications prolonging the qt-interval * abnormal lab tests like: * serum-creatinine \> 3 mg/dl at visit 1 * got and gpt \> 3 x reference limit set * diabetes mellitus with a hba1c \> 9% * patients who are not willing to disclaim a therapy of their erectile dysfunction with vacuum pumps, intravenous injections, sildenafil or other therapies during the trial * severe migraine (more than once a moth during the last 6 months) * intolerance to the study medication * patients who are not able to understand the information and informed consent due to a mental disorder or linguistic barriers * persons who are living in a institution directly under federal government control due to a court order * patients who refuse to renounce drinking grapefruit juice during the trial * women who are pregnant or lactating * women who are not protected from a pregnancy (intake of oral contraceptives alone in insufficient; highly effective methods of birth control have to be used with a failure rate \<1%; barriers: implants, intrauterine-devices (iud´s),diaphragm, condoms, abstinence, partner is vasectomized, spermicides) * patients who participated in other interventional studies within 30 days of study inclusion

Keywords: double-blind placebo controlled cross-over study